Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain

Summary

This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.

Conditions

• Acute Pain
• Low Back Pain, Mechanical

Interventions

BEHAVIORAL

Supported-Self Management (SSM)

Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.

OTHER

Spinal Manipulation Therapy (SMT)

SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.

COMBINATION_PRODUCT

SMT + SSM

Combination Treatment

DRUG

Standard Medical Care (SMC)

Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of North Texas Health Science Center

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• Gert Bronfort, PhD, DC · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2024-06-12

Completion

2024-06-12

FDA Drug

Yes

Countries

• United States

Study Locations